Events

Recall of Device Recall Imagecast PACS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ge Healthcare It.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64740
  • Event Risk Class
    Class 2
  • Event Number
    Z-0773-2014
  • Event Initiated Date
    2011-03-04
  • Event Date Posted
    2014-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116903
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • Reason
    In imagecast pacs versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounted for. these versions of imagecast pacs look for values to be present in the following tags to calculate a measurement from pixels to millimeters (mm): (0020,0030) pixel spacing and, (0018,1164) imager pixel spacing. because the estimated magnification factor is not used, distance meas.
  • Action
    Important Product Information Letters dated March 4, 2011 were sent to all customers that received the defective software. The letters advised customers to upgrade their PACS software version to Imagecast 3.6. The software upgrade can be requested from GE Support via the eService portal or by telephone at 1-800-437-1171. If the customer elects to not upgrade the software, instructions were provided for a new system calibration procedure.

Device

Device Recall Imagecast PACS
  • Model / Serial
    Imagecast PACS versions prior to 3.6.51.01
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: US including states of: AL, AZ, CT, FL, GA, IA, IN, LA, MA, MI, MN, MO, NC, NH, NJ, NY, OH, PA, TX, VA, WI, WV + District of Columbia.
  • Product Description
    Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image and interpretations. Mammongraphic may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.
  • Manufacturer
    Ge Healthcare It

Manufacturer

Ge Healthcare It
  • Manufacturer Address
    Ge Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA